This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | March 14, 2019 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Number of participants with dose limiting toxicities (DLTs)
Primary Outcome 1 - Time Frame: Baseline through day 28
Primary Outcome 2 - Measure: Number of participants with treatment emergent adverse events (AEs)
Primary Outcome 2 - Time Frame: Baseline through up to 2 years or until disease progression
Primary Outcome 3 - Measure: Number of participants with laboratory abnormalities
Primary Outcome 3 - Time Frame: Baseline through up to 2 years or until disease progression
Primary Outcome 4 - Measure: Objective Response Rate
Primary Outcome 4 - Time Frame: Baseline through up to 2 years or until disease progression
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC,
urothelial carcinoma or HNSCC
- Progressed after at least 1 line of treatment and no more than 3 lines of treatment
- At least one measurable lesion as defined by RECIST version 1.1
- ECOG Performance Status 0 or 1
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
- Resolved acute effects of any prior therapy
Exclusion Criteria:
- Known active uncontrolled or symptomatic CNS metastases.
- Major surgery, radiation therapy, systemic anti-cancer therapy or investigational
drug(s) within 4 weeks prior to study entry.
- Active, uncontrolled infection, including COVID-19
- Known or suspected hypersensitivity to PF-06939999
- Inability to consume or absorb study drug
Show More
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Pfizer CT.gov Call Center
Role: Study Director
Affiliation: Pfizer
Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Link: To obtain contact information for a study center near you, click here.
Facility | Status | Contact |
---|---|---|
Scottsdale Healthcare Hospitals d/b/a HonorHealth Scottsdale, Arizona 85258 United States |
Recruiting | |
Virginia G. Piper Cancer Pharmacy Scottsdale, Arizona 85258 United States |
Recruiting | |
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center Miami, Florida 33136 United States |
Recruiting | |
Prisma-Health Institute for Translational Oncology Research Greenville, South Carolina 29605 United States |
Not yet recruiting | |
Henry-Joyce Cancer Clinic Nashville, Tennessee 37232 United States |
Recruiting | |
Oncology IDS Pharmacy Nashville, Tennessee 37232 United States |
Recruiting | |
The University of Texas Houston, Texas 77030 United States |
Recruiting | |
NEXT Oncology San Antonio, Texas 78229 United States |
Recruiting | |
Inova Schar Cancer Institute Annandale, Virginia 22003 United States |
Active, not recruiting | |
Inova Schar Cancer Institute Infusion Pharmacy Fairfax, Virginia 22031 United States |
Active, not recruiting | |
Inova Schar Cancer Institute Fairfax, Virginia 22031 United States |
Active, not recruiting | |
Seattle Cancer Care Alliance Seattle, Washington 98109 United States |
Recruiting | |
University of Washington Medical Center Seattle, Washington 98195 United States |
Recruiting |